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SeaStar Medical Q3: QUELIMMUNE revenue rises to $635,000 as adult AKI trial nears 75% enrolment

🇺🇸 SeaStar Medical Holding Corp (ICU) · Thu 12 Nov 2026

The US device maker reports a net loss of about $4.5 million and $4.0 million in cash, while advancing a PMA submission and a new Breakthrough Device Designation.

SeaStar Medical Holding Corp reported third-quarter 2026 results on 11 November. Net revenue from QUELIMMUNE, its device for sepsis-associated acute kidney injury (AKI) in children, rose to $635 thousand. The company put the increase at 247%. Its net loss for the quarter was about $4.5 million.

QUELIMMUNE is approved under a Humanitarian Device Exemption (HDE). The company said it has met the FDA's post-approval requirements for the SAVE Registry. As general context, an HDE allows marketing of devices for rare conditions without the full evidence of effectiveness needed for a standard premarket approval.

In adults, the NEUTRALIZE-AKI pivotal trial has enrolled 251 of a planned 339 patients, which is roughly 75%. SeaStar has also submitted the first module of a premarket approval (PMA) application. Modular PMA submissions let a sponsor file sections of an application in stages.

On the regulatory and reimbursement side, SeaStar received its seventh Breakthrough Device Designation, this time for sepsis hyperinflammation. The Centers for Medicare & Medicaid Services (CMS) issued new ICD-10-PCS procedure codes, effective 1 October 2026. Cash stood at $4.0 million at the end of the quarter.

What it means for your team

  • Market-access teams should note the new ICD-10-PCS codes effective 1 October 2026, which create a coding pathway for QUELIMMUNE procedures.
  • Regulatory teams can track a staged approach: HDE status in paediatrics, a first PMA module submitted, and a pivotal adult trial about 75% enrolled.
  • Completion of FDA post-approval requirements for the SAVE Registry is a data point for those following post-market obligations for HDE devices.
  • Cash of $4.0 million against a quarterly net loss of about $4.5 million is relevant to anyone assessing the company's capacity to fund its programmes.

Company's press release (SEC filing): SeaStar Medical Holding Corp ↗

Article written by VigiEye from the official source (SeaStar Medical Holding Corp). Claims are the company's own. AI-assisted; check the source before acting.

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